- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702025
Rapid Acclimatization to Hypoxia at Altitude
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1582
- Colorado State University, Dept. of Health and Exercise Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- normotensive (i.e. <140/90 mmHg)
Exclusion Criteria:
- Pregnancy
- nursing mother
- current tobacco use or regular use within the previous two years
- use of prescription medication other than birth control
- asthma or any other type of lung/respiratory dysfunction
- resting oxygen saturation <95%
- unwillingness to abstain from exercise for 48 hours prior to laboratory testing
- use of anticoagulant therapy or have a known or suspected bleeding disorder
- identification of contraindication during screening (i.e. positive stress test)
- any history of mountain sickness (altitude sickness)
- any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives
- history of clinically significant illness within 4 weeks prior to Day 1
- Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1
- receipt of a transfusion or any blood products within 30 days prior to visit 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions. Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions. |
Yellow corn meal in gel capsules
Other Names:
|
ACTIVE_COMPARATOR: Aminophylline
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions. |
National Drug Code (NDC) 0143-1020-01
Other Names:
|
ACTIVE_COMPARATOR: Methazolamide
Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. |
NDC 0781-1072-01
Other Names:
|
ACTIVE_COMPARATOR: Aminophylline+Methazolamide
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide) Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. |
NDC 0143-1020-01 and NDC 0781-1072-01
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
Time Frame: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
|
After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial.
The time taken to cycle a distance equivalent to 7.75 miles will be recorded.
On a separate day the experiment will be repeated in hypoxia.
It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia.
One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
|
The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Respiratory
- Hypoxia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Protective Agents
- Carbonic Anhydrase Inhibitors
- Natriuretic Agents
- Cardiotonic Agents
- Diuretics
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Theophylline
- Aminophylline
- Methazolamide
Other Study ID Numbers
- N66001-10-C-2134 (Other Grant/Funding Number: DARPA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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